Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies

NCT03052712 | Terminated

• 1 other identifier: PI2015_843_0031
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to a large group of emotional and cognitive abilities regulating inter-individuals relationships and it includes mainly theory of mind, emotional information processing and empathy. However, assessment of socio-emotional processes is still largely based on experimental tests that are not validated for clinical purpose. In addition their long duration of administration is not adapted to clinical examination. Finally these tests have not been standardized and normalized in French-speaking population.

Conditions

Alzheimer Disease; Parkinson Disease; Frontal Dementia; Huntington Disease; Traumatic Brain Injury; Stroke

Keywords

Disorders of socio-emotional; Alzheimer; frontal temporal dementia; Parkinson; Huntington; traumatic brain injury; stroke; focal lesions

Outcome Measures

Primary Outcomes (1)

• tests of social cognition (questionnaire)

  standardize and validate in French-speaking population a comprehensive battery of tests of social cognition

  3 years

Study Arms (2)

Patients

ACTIVE COMPARATOR

battery of tests of social cognition

Behavioral: social cognition

Control

ACTIVE COMPARATOR

battery of tests of social cognition

Behavioral: social cognition

Interventions

social cognition BEHAVIORAL

battery of tests of social cognition

Control; Patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form (ICF)
• Male or female, aged 20 to 80 years inclusive at the time of signing ICF
• French-speaking
• reliable informant
• Controls:
• derived from the general population and consenting to participate in the study
• Patients:
• MMS\>18
• Patients followed for mild or major neurocognitive disorder related to :
• Alzheimer's disease
• Frontotemporal lobar degeneration
• Lewy bodies disease
• Parkinson's disease
• Huntington's disease
• Progressive supranuclear palsy

You may not qualify if:

• Illiteracy
• mental retardation
• visual or motor deficit preventing reading, drawing or writing (scores on the reading, drawing or sentence writing subtests of the MMSE = 0)
• hearing impairment interfering with understanding of instructions,
• history of brain disease, including head injury with loss of consciousness lasting \> 15 minutes, stroke, coma or loss of consciousness lasting \> 15 minutes, followed for sclerosis or other brain disease, brain radiation therapy, epilepsy currently requiring treatment
• history of psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (major depressive disorder or other condition) currently requiring treatment or requiring a stay \> 2 days in a psychiatry unit or anxiety requiring more than one medication at the present time
• alcoholism (mean alcohol consumption \> 3 standard drinks/day or history of alcohol withdrawal)
• use of opiates or other illicit drugs during the previous 3 months or causing withdrawal syndrome
• ongoing antidepressant or antiepileptic treatment
• anxiolytic or hypnotic treatment initiated or increased during the previous month
• general anaesthesia during the previous 3 months
• history of heart surgery with cardiopulmonary bypass
• comorbidities affecting cognition (respiratory, renal, liver, heart failure…)
• women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile)
• persons placed under judicial protection

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Huntington Disease; Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivier GODEFROY, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: September 9, 2016
• Primary Completion: September 8, 2019
• Study Completion: September 8, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

FR (1)